University of Pennsylvania 11th annual conference on statistical issues in clinical trials: Estimands,missing data and sensitivity analysis (morning panel session)

Guidance for Industry E9 Statistical Principles for Clinical Trials. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER) Geneva: ICH, 1998.

National Research Council. The prevention and treatment of missing data in clinical trials. Panel on handling missing data in clinical trials. committee on national statistics, division of behavioral and social sciences and education. Washington, DC: The National Academies Press, 2010.

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH Harmonised Guideline. Estimands and sensitivity analysis in clinical trials, http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E9/E9-R1EWG_Step2_Guideline_2017_0616.pdf (2017; accessed 6 March 2019).

Rockhold FW Ruberg SJ . ICH-E9 reflections and considerations. Pharm Stat 2008; 7(4): 233–235.

CONSORT. Transparent reporting of trials. http://www.consort-statement.org/ (2010; accessed 17 October 2018).

Tamblyn R Eguale T Huang A , et al. The incidence and determinants of primary nonadherence with prescribed medication in primary care: a cohort study. Ann Intern Med 2014; 160(7): 441–450.

Span P . The clinical trial is open, the elderly need not apply health. The New York Times, 13 April 2018, https://www.nytimes.com/2018/04/13/health/elderly-clinical-trials.html

Mosteller F Tukey JW . Data analysis, including statistics. In: Jonas LV (ed.) The collected works of John W. Tukey: philosophy and principles of data analysis 1965–1986, Vol. IV. Boca Raton, FL: CRC Press, 1987, pp. 601–720.

Balas EA Boren SA . Managing clinical knowledge for health care improvement. In: Bemmel J McCray AT (eds) Yearbook of medical informatics 2000: patient-centered systems. Stuttgart: Schattauer Verlagsgesellschaft mbH, 2000, pp. 65–70.

Permutt T Li F . Trimmed means for symptom trials with dropouts. Pharm Stat 2017; 16(1): 20–28.

Alonso A Van der Elst W Molenberghs G , et al. On the relationship between the causal-inference and meta-analytic paradigms for the validation of surrogate endpoints. Biometrics 2015; 71(1): 15–24.

Oxford English Dictionary. http://www.oed.com/ (2019; accessed 9 January 2019).

Fisher RA . The design of experiments. 6th ed. Edinburgh: Oliver and Boyd, 1951, p. 26.

Armitage P . Fisher, Bradford Hill, and randomization. Int J Epidemiol 2003; 32(6): 925–948; discussion 945.

Molenberghs G . Incomplete data in clinical studies: analysis, sensitivity, and sensitivity analysis. Drug Inf J 2009; 43(4): 409–429.

Lehmann EL Casella G . Theory of point estimation. New York: Springer Science & Business Media, 2006.